FDA has approved Zohydro ER, the first extended-release, single-entity hydrocodone-containing drug product. To enhance safe and appropriate use, Zohydro ER’s labeling reflects the newly required ER/LA opioid analgesic class safety labeling changes and will be subject to the recently announced class postmarket study requirements. FDA also responded to a citizen petition (CP) concerning opioid medications and abuse-deterrence.
FDA Approves Zohydro ER and Responds to CLAAD CP
October 25, 2013
Approval letter to Zohydro ER manufacturer, Zogenix Zohydro ER Labeling
- Summary Review for Regulatory Action for Zohydro ER
FDA Response to Citizen Petition: Center for Lawful Access and Abuse Deterrence (CLAAD), Docket ID FDA-2013-P-0703-0001
The citizen petition requests, among other things, that FDA reject applications for new solid oral dosage form opioid medications lacking abuse-deterrent properties.